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Model Number 6660 |
Device Problem
Lens washers, failure of (1367)
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Patient Problem
Twitching (2172)
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Event Date 01/28/2014 |
Event Type
malfunction
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Event Description
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Customer called to report a blood leak that occurred during treatment.Name and function of complainant: same as reporter.Customer called to report blood leak during cycle 1.Customer stated there was a blood leak alarm and when the centrifuge chamber door was opened, there was blood leaking from the neck of the centrifuge bowl.Customer stopped the procedure without returning any blood/products to the patient.Css asked customer if there were any alarms prior to the blood leak alarm.Customer states there were multiple empty a/c alarms.Css asked if there was any clotting or occlusions observed in the kit when it was removed.Customer stated there was no clotting or any occlusions in the kit.Css asked if patient was stable, and customer stated patient was stable and asymptomatic.They were able to start another procedure on this patient.No kit was returned for investigation.
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Manufacturer Narrative
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Batch record review of lot a908 was conducted.There were no non-conformities related to this type of failure for this lot.Lot met release requirements.Trends have been reviewed on a lot by lot basis for this complaint category and no trend has been detected for this specific lot.The assessment is based on information available at the time of the investigation.No product was returned by customer for investigation; therefore, no root cause could be determined at this time.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.
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Search Alerts/Recalls
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